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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K013621
Device Name BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
Applicant
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact LESLIE WOOD
Correspondent
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact LESLIE WOOD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/05/2001
Decision Date 04/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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